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The safety and efficacy of palbociclib in older patients with advanced breast cancer in a real-world setting

Journal of Cancer Metastasis and Treatment 2022年第1期8卷 15-27页

作者： Etienne Gouton Louis Tassy Joëlle Micallef amir meskine Renaud Sabatier Maud Cecile-Herry Cécile Braticevic Anthony Goncalves Frederic Viret Alexandre de Nonneville Coline Montegut Franck Rouby Frederique Rousseau Department of Medical Oncology Institut Paoli-CalmettesMarseille 13009France Aix-Marseille Univ CNRS U7258INSERM U1068Institut Paoli-CalmettesCRCMMarseille 13009France Department of Clinical Pharmacology Régional Center of Pharmacovigilance Marseille-Provence-CorseAssistance Publique-Hôpitaux de MarseilleAix-Marseille Univ.Neurosciences InstituteMarseille 13005France

Aims:Palbociclib has been approved in combination with endocrine therapy(ET)for hormone receptor-positive(HR+)/human epidermal growth factor receptor 2-negative(HER2-)advanced breast cancer(ABC),regardless of *** though ABC is one of the most prevalent cancers in older patients,very few patients≥65 years old were included in pivotal ***,the current study evaluated the safety and efficacy of palbociclib in“real-world”routine treatment of unselected older patients with HR+/***:Data were collected on patients>70 years old who were treated with palbociclib plus ET for HR+/HER2-ABC in our *** analyzed safety data(CTCAE v4.0 criteria)and outcomes,such as progression-free survival(PFS)and overall survival(OS),as well as any associations between main geriatric characteristics and our ***,we assessed safety at a national level by analyzing all palbociclib-related adverse events(AEs)reported in the French Pharmacovigilance Database(FPVD)during the same ***:From February 2016 to July 2019,52 patients were identified with a median age of 80.9 years,of whom 88%presented an *** most common grade 3-4 AE was neutropenia(64%).Median PFS and OS were nine months and not reached,*** FPVD reports 227 cases of palbociclib-related AEs,with older and younger patients sharing similar ***:Palbociclib is well tolerated in older patients with efficacy comparable to that in younger ***,the addition of palbociclib to ET should be evaluated individually in this older and frailer subgroup.

关键词： Advanced breast cancer palbociclib older patients tolerance efficacy pharmacovigilance

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